Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI

Completed · Not applicable

Conditions studied: Insomnia Chronic, Mild Traumatic Brain Injury

In brief

This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment availability and utilization within the military health system. The version of the internet-guided CBT-I program being studied has been customized specifically for military service members. The study will assess if the customized internet-guided CBT-I program will positively improve clinical measures of insomnia and quality of life outcomes in active or retired service members with primary insomnia and associated mild traumatic brain injury.

Key facts

Study ID

NCT04377009

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

125

Starts

2020-07-07

Expected to finish

2023-04-30

Last updated by the study team

2023-08-21

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-64
• Service member or veteran
• Ability to provide electronic informed consent and follow study-related instructions
• Presence of clinical insomnia for a period of at least 1 month prior to consent as confirmed by self-reported Insomnia Severity Index (ISI) score ≥15 and Pittsburgh Sleep Quality Index ≥5
• History of mild traumatic brain injury ≥6 months prior to consent, including blast-related, as confirmed by a telephone administered traumatic brain injury screener
• Reliable access to a telephone and the Internet via their computer or smartphone
• Stable regimen of medications for sleep or potentially affecting sleep over prior 1 month as confirmed by clinical history review

You may not qualify if…

• Current or previous cognitive behavioral therapy for insomnia (CBT-I) or electronic CBT- I intervention; participants may still receive other approved therapies provided via standard of care
• Life expectancy of <6 months
• Rapidly progressive illnesses (i.e., late-stage cancer, neurodegenerative conditions, major organ failure, etc.)
• Self-reported history of moderate to severe substance use disorders with the exception of nicotine
• Active bipolar disorder or psychosis that could be worsened by mild sleep restriction as part of electronic CBT-I
• Routine irregular work schedules or sleep patterns defined as shift work greater than 1 day per week
• Any other considerations that in the view of the principal investigator may adversely affect patient safety, participation, or scientific validity of the data being collected

Where it is running

• Uniformed Services University — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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